Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

July 8, 2013 updated by: Hua Zheng, Huazhong University of Science and Technology

Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ischemia reperfusion injury (IRI) induced renal failure after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effects of IRI after organ transplantation various strategies aimed at the different pathophysiological processes of IRI have been investigated. Remote ischemic preconditioning (RIPC) is one such strategy where brief IRI of one organ protects other organs from sustained IRI. Many studies have shown that RIPC protects heart, muscle flaps, stomach, liver, lungs, and kidneys from IRI. RIPC of the limb with a tourniquet is a safe and convenient method of preconditioning organs against IRI. However, the efficacy of RIPC in patients undergoing living donor kidney transplantation need to be established and mechanism of early and late RIPC, such as whether the donor should undergo remote preconditioning or the recipient, need to be investigated.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
  • Living donors
  • Compatible ABO blood type
  • PRA < 20%

Exclusion Criteria:

  • Re-transplant patients
  • Those with peripheral vascular disease affecting the lower limbs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
EXPERIMENTAL: donor
Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
Device: remote ischaemic preconditioning
Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Other Names:
  • RIPC
EXPERIMENTAL: recipient
recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
Device: remote ischaemic preconditioning
Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Other Names:
  • RIPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Creatine Concentration of the Recipients
Time Frame: within the first 3days after the operation
Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping
within the first 3days after the operation
Urinary Output of the Recipients Postoperatively
Time Frame: within the first 3days after the operation
Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation
within the first 3days after the operation
Plasma Concentration of NGAL in the Recipients
Time Frame: within the first 24hours after the operation
Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping
within the first 24hours after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Rejection of Transplanted Kidney
Time Frame: before discharge
biopsy-confirmed, clinically symptomatic
before discharge
Delayed Graft Function
Time Frame: before discharge
Delayed Graft Function according to the clinical symptoms
before discharge
Length of Postoperative Hospital Stay
Time Frame: before discharge
time from the day of operation to the day of discharge for the recipients
before discharge
Total Costs During the Hospitalization
Time Frame: from the admission to the discharge of the patients
Total costs from the admission to the discharge of the recipients
from the admission to the discharge of the patients
Urine Concentration of NAG Preoperatively in Recipients
Time Frame: before operation
Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation
before operation
Urine Concentration of NAG Postoperatively in Recipients
Time Frame: within the first 24hours after the artery unclamping
Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients
within the first 24hours after the artery unclamping
Urine Concentration of RBP Preoperatively in the Recipients
Time Frame: before the operation
Urine concentration of retinol binding protein (RBP) before the operation in the recipients
before the operation
Urine Concentration of RBP Postoperatively in the Recipients
Time Frame: within the first 24hours after the artery unclamping
Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients
within the first 24hours after the artery unclamping
Plasma Concentration of SOD in the Recipients
Time Frame: within 24hours after the operation
Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
within 24hours after the operation
Plasma Concentration of MDA in the Recipients
Time Frame: within the first 24hours after the operation
Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
within the first 24hours after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Collaborators

B. Braun Medical SA

Investigators

  • Study Chair: Yuke Tian, M.D., Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 2, 2011

First Posted (ESTIMATE)

February 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2013

Last Update Submitted That Met QC Criteria

July 8, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJMZK201001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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